EBV Positive Nasopharyngeal Carcinoma Treated With Concur... | NCT03656965

Studies
EBV Positive Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug

NCT03656965

Sponsor

Kuwait Cancer Control Center

Status

Unknown status

Last Update Posted

Sep 4, 2018Actual

Enrollment

50Estimated

Phase

Phase 3

Conditions

Drug Use for Unapproved Schedule

Interventions

Acyclovir 800 MG
Radiotherapy and chemotherapy

Countries

Kuwait

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2018Actual

Primary Completion Date

May 2021Estimated

Completion Date

May 2021Estimated

First Submitted Date

Aug 26, 2018

First Submission Date that Met QC Criteria

Aug 30, 2018

First Posted Date

Sep 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2018

Last Update Posted Date

Sep 4, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

PCR-DNA of EBV test is a good prognostic indicator for survival after treatment (report: Prognostic Impact of Plasma, Epstein-Barr Virus DNA in Patients with Nasopharyngeal Carcinoma Treated using Intensity-Modulated Radiation Therapy.

The chances of the local recurrence or metastasis are higher in the patients at same stage with positive PCR-DNA of EBV in Nasopharyngeal carcinoma after same treatment.(ref.) Antiviral drugs have been used to inhibit EBV replication and target viral DNA polymerase are Foscarnet and phosphonoacetic acid both interact directly with the pyrophosphate-binding site of the enzyme, where Acyclovir as antiviral drug act at two levels: as competitive alternative substrates, competing with GTP on the substrate-binding site, and as DNA chain terminators, by incorporating into the growing DNA chain and blocking its elongation due to their acyclic structure.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Antiviral Drug with Chemoradiotherapy	Experimental	Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.	Drug: Acyclovir 800 MG Combination Product: Radiotherapy and chemotherapy
Chemoradiotherapy	Other	Patients will receive concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.	Combination Product: Radiotherapy and chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acyclovir 800 MG	Drug	Acyclovir tablets 800 mg per day during the whole course of treatment Or Placebo.	Antiviral Drug with Chemoradiotherapy

Measure	Description	Time Frame
Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III.
Stage II-IVB
Requiring primary concomitant Radiotherapy and Chemotherapy.
No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
Positive PCR-DNA EBV
≥ 18 years of age
ECOG performance status 0-1
WBC ≥ 4,000/µl, platelets ≥ 100,000/µl; serum creatinine ≤ 1.6 mg/dl or 24 hr. calculated creatinine clearance ≥ 60 ml/min (see Section 3.1.6).
Pre-treatment evaluation of tumor extent and tumor measurement.
Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment.
Signed study-specific consent form prior to study entry Assessment.

Exclusion Criteria:

Prior radiotherapy to the head and neck or any prior chemotherapy ≤ 6 months prior to study entry.
Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin ≤ 5 years
Evidence of distant metastasis.
on any experimental therapeutic cancer treatment.
major medical or psychiatric illness.
pregnant females.
Age ≤ 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Khaled AlSaleh, M.D	Chairman, Radiation Oncology Department	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D000077274	Nasopharyngeal Carcinoma

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574

ID	Term
D000212	Acyclovir
D011878	Radiotherapy
D004358	Drug Therapy